An intergroup randomised trial of rituximab versus a watch and wait strategy in patients with advanced stage, asymptomatic, non-bulky fillicular lymphoma - Watch and Wait

Phase 1

• Conditions: Advanced stage, asymptomatic, non-bulky follicular lymphoma (grades 1, 2 and 3a)

• Registration Number: EUCTR2004-001621-16-CZ
• Lead Sponsor: niversity College London (UCL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-18
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- min. age 18 years, no upper limit
- follicular lymphoma grade 1,2 and 3a
- stage II, II and IV disease
- asymptomatic without B symptoms or severe pruritus
- blood count : Hb more than 10g/dl, Neuts more than 1,5 x 109/l, PLT more than 100 x 109/l and less than 5 x 109/l circulating tumour cells
- renal functions: creatinine less than 2 x UNL for reasons other than lymphoma
- normal liver function
- Low tumour burden defined as:
LDH within normal range
largest nodal or extranodal mass less than 7 cm
no more than 3 nodal sites with a diameter more than 3 cm
not significant serious effusions detectable clinically or on chest X-ray
spleen enlargement less than or equal to 16 cm by CT
- no other (non-lymphoma) immediately life-threatening disease
- must have the disease measurable in at least 2 dimension either clinically or radiologically
- entry within 3 months of biopsy with no prior therapy
- ECOG performance status 0-1
- no evidence of histological transformation
- no second malignancy unless treated with curative intent and patient has been disease-free for more than 2 years
- if second malignancy was basal cell carcinoma or squamouus cell carcinoma of the skin or carcinoma of the cervix, the patient need only be currently disease-free
- patient must be able to give informed consent
- no critical organ failure or organ compression
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with known to be HIV positive
- patients with Hepatitis B infection (required tests - see appendix 3)
- pregnant or breastfeeding patients
- women of childbearing potential not willing to take adequate contraceptive precautions if randomised to rituximab containg arm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified